This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma.
* 1. Aged 18 to 70 years, male or female.
2. Patients with a confirmed diagnosis of relapsed/refractory multiple myeloma according to the IMWG diagnostic criteria.
3. Patients who have received at least three prior treatment regimens (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibody-based chemotherapy regimens) and have documented disease progression during or within 12 months of their most recent anti-myeloma treatment.
Serum M-protein level: IgG type M-protein level ≥ 10 g/L, IgA, IgD, IgE, IgM type M-protein level ≥ 5 g/L
1. Patients with graft-versus-host disease (GVHD) or requiring long-term use of immunosuppressants.
2. Patients with a history of BCMA-targeted therapy.
3. Patients who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks prior to apheresis, two auto-HSCTs, or prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Monoclonal antibody therapy within 21 days prior to apheresis.
Single group
Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel)
DrugEque-cel consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that contains a unique CAR structure with a fully human single-chain variable fragment (scFv).
Safety endpoint (Part 1)- Adverse Event（AEs）
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria).
Safety endpoint (Part 1)-CRS
Incidence and severity of cytokine release syndrome (CRS； based on the 2019 ASTCT criteria）
Safety endpoint (Part 1)-ICANS
Incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS).( based on the 2019 ASTCT criteria)
Efficacy endpoint (Part 2): Independent Review Committee (IRC)-assessed ORR
Rate of best response (PR, very good PR, CR, sCR) after Eque-cel infusion in all subjects at the time the last subject completed the 6-month follow-up.
Safety endpoint (Part 2)- Adverse Event（AEs）
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to 2019 ASTCT criteria).
Efficacy endpoint -Investigator-assessed overall response rate (ORR)
Rate of best response (PR, very good PR, CR, sCR) after Eque-cel infusion for all subjects at the time the last subject completed the 6-month follow-up.
Efficacy endpoint -IRC- and investigator-assessed ORR
Rate of best response (PR, VGPR, CR, sCR) within 1 month, 3 months, and 6 months after Eque-cel infusion.
Efficacy endpoint -IRC and investigator-assessed duration of response (DOR)
The period from the first response (PR, VGPR, CR, sCR) to the date of the first documented evidence of disease progression or death from any cause, as defined by the IMWG criteria after treatment.
Exploratory endpoints - Immunogenicity
Prevalence and titer of confirmed human anti-CAR antibodies in peripheral blood.
Exploratory endpoints -replication competent lentivirus (RCL)
Prevalence of replication-competent lentivirus (RCL) in peripheral blood.
Map coordinates are unavailable for these locations. Locations are shown below instead.
JapanJapanJapanClick on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
